Clinical Operations Manager

Clinical Operations Manager

CK Group are recruiting for a Clinical Operations Manager to join a Swiss high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.

The position will be for a 12-month contract, located near at the clients office near Basel, the rate for this role will be 69.49 CHF per hour.

Job Responsibilities :

The Clinical Operations Manager is driving the development of the operational trial related documents and procedures, as well as setting-up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out.

For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESPs.

• Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables
• Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work;

identify areas of concern and escalate to the Clinical Trial team (CTT)

• Lead the development of trial-related operational documents
• Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators)
• Resolve operational issues in a proactive and timely fashion
• Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions

Candidate’s Requirements :

• Bachelor of Science degree or equivalent University degree in life sciences or healthcare
• 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report
• Experience in working in global cross-functional and multicultural teams
• Experience in selecting and managing External Service Providers , including performance assessments and finance management
• Previous experience working with electronic data capture, electronic Trial Master File, and Clinical Trial Management Systems
• Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
• Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint)
• Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities
Vor 30+ Tagen